HEARTPORT ENDOCORONARY SINUS CATHETR

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

HEARTPORT, INC.

The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Endocoronary Sinus Cathetr.

Pre-market Notification Details

Device IDK964248
510k NumberK964248
Device Name:HEARTPORT ENDOCORONARY SINUS CATHETR
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City,  CA  94063
ContactKevin F Macdonald
CorrespondentKevin F Macdonald
HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City,  CA  94063
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-24
Decision Date1997-01-22
Summary:summary

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